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The WAVE O Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The WAVE O cage is an expandable PEEK cage of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

This document is a 510(k) summary for the WAVE O Cage, an intervertebral body fusion device. It does not describe a study involving artificial intelligence or a medical imaging device. Therefore, I cannot provide the requested information.

The document explicitly states under section "6. CLINICAL TEST SUMMARY" that "No clinical studies were performed." and under section "5. NON-CLINICAL TEST SUMMARY" that "The results of this testing indicate that the WAVE O Cage is equivalent to predicate devices." This implies that the device's performance was established through non-clinical testing and comparison to predicate devices, not through a study with acceptance criteria and reported device performance in the way described in your request for AI-enabled devices.

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